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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05687903




Registration number
NCT05687903
Ethics application status
Date submitted
9/01/2023
Date registered
18/01/2023

Titles & IDs
Public title
A Study of TAK-861 in Participants With Narcolepsy Type 1
Scientific title
A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
Secondary ID [1] 0 0
2022-001654-38
Secondary ID [2] 0 0
TAK-861-2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Narcolepsy Type 1 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAK-861
Treatment: Drugs - Placebo

Experimental: TAK-861 Dose 1 - Participants will receive TAK-861 dose 1, orally, from Day 1 up to Weeks 8 or 12.

Experimental: TAK-861 Dose 2 - Participants will receive TAK-861 dose 2, orally, from Day 1 up to Weeks 8 or 12.

Experimental: TAK-861 Dose 3 - Participants will receive TAK-861 dose 3, orally, from Day 1 up to Weeks 8 or 12.

Experimental: TAK-861 Dose 4 - Participants will receive TAK-861 dose 4, orally, from Day 1 up to Weeks 8 or 12.

Placebo comparator: Placebo - Participants will receive TAK-861 matching placebo tablets, orally, from Day 1 up to Weeks 8 or 12.


Treatment: Drugs: TAK-861
TAK-861 tablets

Treatment: Drugs: Placebo
TAK-861 placebo matching tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline to Week 8 in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [1] 0 0
Change from Baseline to Week 8 in Epworth Sleepiness Scale (ESS) Total Score
Timepoint [1] 0 0
Baseline, Week 8
Secondary outcome [2] 0 0
Weekly Cataplexy Rate at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Occurrence of at Least One Related Treatment-emergent Adverse Event (TEAE)
Timepoint [3] 0 0
Baseline up to approximately 16 weeks

Eligibility
Key inclusion criteria
1. The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).

Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
2. The participant has body mass index (BMI) within the range 18 to 40 kilogram per square meter [kg/m^2] (inclusive).
3. The participant has an International Classification of Sleep Disorders, 3rd Edition (ICSD-3) diagnosis of narcolepsy type 1 (NT1) by polysomnography (PSG)/Multiple Sleep Latency Test (MSLT), performed within the past 10 years.
4. The participant is positive for the human leukocyte antigen (HLA) genotype HLA-DQB1*06:02 or results from cerebrospinal fluid (CSF) testing indicate the participant's CSF orexin (OX)/hypocretin-1 concentration is <110 picograms per milliliter ([pg/mL] (or less than one-third of the mean values obtained in normal participants within the same standardized assay).
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.
2. The participant has medically significant hepatic or thyroid disease.
3. The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell cancer).
4. The participant has clinically significant coronary artery disease, a history of myocardial infarction, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
5. The participant has a clinically significant history of head injury or head trauma.
6. The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
7. The participant has one or more of the following psychiatric disorders:

1. Any current unstable psychiatric disorder.
2. Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, intellectual disability, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
3. Current diagnosis or history of substance use disorder as defined in the DSM-5.
4. Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.
8. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation.
9. The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen.
10. The participant's renal creatinine clearance (Cockcroft-Gault Equation) is =50 mL/minute.
11. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >1.5 times the upper limit of normal (ULN).
12. The participant is considered by the investigator to be at imminent risk of suicide or injury to self, others, or property, or the participant has attempted suicide within the past year.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/12/2023
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research, Sleep and Circadian Research Group - Glebe
Recruitment postcode(s) [1] 0 0
2037 - Glebe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
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Massachusetts
Country [8] 0 0
United States of America
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Michigan
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United States of America
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Missouri
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Virginia
Country [15] 0 0
Finland
State/province [15] 0 0
Uusimaa
Country [16] 0 0
France
State/province [16] 0 0
Haute-Garonne
Country [17] 0 0
France
State/province [17] 0 0
Herault
Country [18] 0 0
France
State/province [18] 0 0
Isere
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
Germany
State/province [20] 0 0
Bayern
Country [21] 0 0
Germany
State/province [21] 0 0
Mecklenburg-Vorpommern
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Hamburg
Country [24] 0 0
Italy
State/province [24] 0 0
Bologna
Country [25] 0 0
Italy
State/province [25] 0 0
Lazio
Country [26] 0 0
Italy
State/province [26] 0 0
Molise
Country [27] 0 0
Japan
State/province [27] 0 0
Akita
Country [28] 0 0
Japan
State/province [28] 0 0
Hukuoka
Country [29] 0 0
Japan
State/province [29] 0 0
Kumamoto
Country [30] 0 0
Japan
State/province [30] 0 0
Osaka
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Japan
State/province [32] 0 0
Nagakute
Country [33] 0 0
Japan
State/province [33] 0 0
Yokohama
Country [34] 0 0
Netherlands
State/province [34] 0 0
Noord-Brabant
Country [35] 0 0
Netherlands
State/province [35] 0 0
Noord-Holland
Country [36] 0 0
Norway
State/province [36] 0 0
Oslo
Country [37] 0 0
Spain
State/province [37] 0 0
Alava
Country [38] 0 0
Spain
State/province [38] 0 0
Castellon
Country [39] 0 0
Spain
State/province [39] 0 0
Valencia
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Spain
State/province [40] 0 0
Barcelona
Country [41] 0 0
Spain
State/province [41] 0 0
Madrid
Country [42] 0 0
Sweden
State/province [42] 0 0
Vastra Gotalands Lan
Country [43] 0 0
Switzerland
State/province [43] 0 0
Aargau (de)
Country [44] 0 0
Switzerland
State/province [44] 0 0
Ticino (it)
Country [45] 0 0
Switzerland
State/province [45] 0 0
Bern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05687903